- Graduated with a PhD in Molecular Biology, I have gained strong knowledge regarding angiogenesis process (VEGF, Cellular Pathways) during tumor development (especially Breast Cancer) and siRNA/miRNA development.
- For 10 years I have been in charge of setting up and managing clinical trials as a Clinical Project Manager across Europe and Middle East in various therapeutic areas. This has allowed me to gain strong KOL networks in different therapeutic areas and to gain a real expertise in clinical trials development/management in addition to Medical Affairs strategy.
- MSL since June 2010, I became afterwards MSL Manager (Europe) in April 2013 for Bavarian Nordic. This line management experience has then been strengthen when I took the responsibility for the European clinical development of two Biomarkers Assays for two Companies (Inivata Ltd and Oncoplex Dx) with a focus on NSCLC/Breast and a team of 10 people to manage across Europe.
- Currently I am responsible for the Launch of two Products in infectious disease (Antibiotics / Antifungal) and responsible for a team of 15 people (France and Middle East).
- Involved in both pre and post-launch activities which has enabled me to build relationships with physicians identified as KOLs alongside colleagues in order to educate the field sales force.
- I am specialized in setting up Investigator Sponsored Studies due to my strong background in clinical trials management.
- Organized, diplomatic and take pride in having expert knowledge of my products which leads to the success of your product launch/development.
Country Medical Affairs Leader Paris, France
Since April 2016
Currently I am responsible for the Launch of two Products in infectious disease (Antibiotics / Antifungal) and responsible for a team of 15 people (France and Middle East).
- Responsible of defining / implementing the Medical Affairs strategy in France
- Discussion / Lunch of IITs – Feasibility of company sponsored trials
- Management Team 3 MSLs – 8 KAMs
- Advisory Board set up / Management
- Development of educational program (internal/external)
- Congress strategy set up
Since September 2009
My company is based in UAE and we cover Middle east and Europe regarding all Clinical Study activities including but not limited to: - Monitoring Phase II-IV several clinical trials with paediatrics and adults patients - Site contract negotiations (Hospital, Investigator fees) - Site initiation and co-ordination Interim monitoring visits, Site management, Site close-outs - Serious Adverse Event reporting, follow up, reconciliation (Meddra) - Regulatory submissions - Vendors management (For SAE, eCRF, Samples, IVRS, MRI, Scanner, Drug shipment...) - SOPs Writing (for Quality assurance Depatment) - Medical Writing, Preparation of study documents (ICFs, CRF...)
Global Medical Affairs Manager - Europe
April 2015 --- April 2016
In charge of developing/maintaining clinical collaborations with Pharma companies and KOLs across Europe. Attend key congresses in US and Europe. Deep knowledge of NSCLC landscape and associated treatment algorithm.
Clinical Development Consultant - Europe
October 2014 --- September 2015
In charge of developing/maintaining clinical collaborations with KOLs based in France and UK. Attend key congresses in US and Europe. Management of Investigator Sponsored Studies using NGS/Liquid Biopsy and determination of clinical utilities (mainly in Lung and Breast Cancer). Development/conception of international observational study.
Manager, Medical Affairs and Clinical Development - Europe
April 2013 --- March 2015
I have a strong KOLs network across Europe within Prostate Cancer (Mainly in UK, France and Belgium). I am an expert of Castrate Resistant Prostate Cancer field (including but not limited to Abiraterone, Enzalutamide, Docetaxel, Cabazitaxel, Radium 223, denosumab, Cabozantinib, ARN509, Tasquinimod, Orteronel, Sipuleucel-T, LHRH agonist/antagonist ….) My main responsibilities are: - Scientific & medical communication in oncology adressed to UK, Belgium and French hospitals stakeholders (KOL & Health care professionnals) for an innovative Vaccine in mCRPC patients. - Develop the company notoriety deploying adapted communication to create a favorable environment for the market access. - Training CRA/MSL - Attend all major congress in Europe in relation with Prostate Cancer. - Advisory board animation management / Stand alone meeting organization / Patient association partnership.
October 2010 --- March 2013
Freescience is a Network of Four Freelance Medical Writers who can offer on a freelance basis: - Conception/Design of Scientific Research Projects (Protocol design and writing, Case Report Form Design, Investigator Brochure writing, Informed patient leaflet) - Analysis/ Reporting of Scientific Data (Clinical Study Report, Bridging data packages, Pharmacovigilance report (PSUR), Common Technical Document (Module2 and 5)) - Communication/Scientific Information (Publication, Product monograph Symposium coverage, Abstracts, Posters, Slides, Newsletters, Word and Image processing, Graphs, Illustrations, Drawing, Translation (English/French – French/English)
Medical Science Liaison (MSL) Europe - Oncology and Medical Device
June 2010 --- March 2013
As a Medical Sciance Liaison (MSL) covering Europe, I am mainly in charge of: - Discussing and providing scientific and therapeutic information to professionals and researchers in the healthcare industry / Hospitals (KOLs) - Developping and maintaining strong relationships with clinicians and scientists - Creating early awareness and acceptance of the scientific evidence in support of new and existing products and claims - Researching and providing relevant scientific information to professionals - Setting up Investigators Sponsores Studies and discussing with KOLs how to conduct such studies. - Training of sale teams - Conducting/Setting up Advisory Boards
Clinical Project Manager (CPM)
October 2008 --- October 2009
Managment of clinical trials in Europe from feasability to final report. Writing of trial documents (Consentement, Monitoring Guidelines ...) for international studies.
Clinical Research Associate (CRA)
October 2007 --- September 2008
Outsourcing within Baxter SAS Setting up of Phase IIIb study in elderly people
Clinical Research Associate (CRA)
April 2007 --- August 2007
Monitoring of a Phase III Study in Saudi Arabia. Meningococcal vaccine - Adult and Paediatric - 7 sites (around 40 patients per site)
Skills and Expertise
clinical researchMedical Affairsoncologyimmuno-oncologylungprostatebreasthaematologyclinical trialInteract with KOLPresent data at congressmedical writingliquid biopsyBiomarkersSet up a clinical study
PhD in Oncology -Effect Extracellular Matrix in Breast Cancer from Université de Reims Champagne-Ardenne in 2007
Training and Certification